High Dose Vitamin C for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether high doses of Vitamin C (High Dose Ascorbic Acid or HDAA), combined with the chemotherapy drug melphalan and followed by a type of stem cell transplant, can safely and effectively treat multiple myeloma that has not responded to other treatments. Multiple myeloma is a blood cancer affecting plasma cells. The trial aims to determine if a lower dose of melphalan combined with Vitamin C is effective and gentler on the body. It is suitable for individuals who have undergone multiple treatments for multiple myeloma and whose disease has worsened in the past six months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those using warfarin and insulin-dependent diabetics. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that high-dose vitamin C, administered through an IV, has been safely used in early studies for various types of cancer. Patients in these studies did not report major safety issues, even with doses as high as 1.5 grams per kilogram of body weight, suggesting that the body generally handles high doses well.
For multiple myeloma, a type of blood cancer, high-dose vitamin C has shown potential by possibly helping to kill cancer cells through the creation of harmful substances.
Melphalan, a chemotherapy drug, has already received FDA approval for treating multiple myeloma at higher doses than those used in this study. This trial uses only half of the standard dose, which might lead to fewer side effects.
Overall, both treatments in this trial appear well-tolerated based on previous studies and dosages. However, as this trial is in an early stage, its main goal is to further confirm the safety of using these treatments together.12345Why are researchers excited about this trial's treatments?
Most treatments for multiple myeloma, like chemotherapy and targeted therapies, focus on killing cancer cells directly. However, high dose Vitamin C, or ascorbic acid (HDAA), offers a unique approach by potentially enhancing the effectiveness of chemotherapy drugs like melphalan. Researchers are excited about HDAA because it could make cancer cells more sensitive to chemotherapy, improving treatment outcomes. The use of high doses of Vitamin C is also intriguing due to its potential to boost the immune system and reduce side effects, offering a complementary approach to traditional treatments.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that high-dose vitamin C can destroy multiple myeloma cells by producing substances harmful to these cancer cells. In this trial, participants will receive varying doses of high-dose vitamin C combined with the chemotherapy drug melphalan. Studies have found that vitamin C can enhance melphalan's effectiveness, even at lower doses. This combination might reduce the side effects typically associated with high doses of melphalan. High-dose vitamin C also appears to fight tumors by altering cancer cell behavior and strengthening the immune system. While these findings are promising, further research is needed to fully understand its effectiveness in treating multiple myeloma.12367
Who Is on the Research Team?
Carolina Schinke, MD
Principal Investigator
University of Arkansas
Are You a Good Fit for This Trial?
This trial is for adults over 18 with relapsed refractory multiple myeloma who've had at least three prior treatments and disease progression within the last six months. They must have enough stored stem cells, specific levels of proteins or plasmacytosis indicating active disease, and a stable neutrophil count without growth factor support.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a test dose of HDAA alone at screening, then proceed to either 75, 100, or 125 gm on day -4, HDAA combined with melphalan 100 mg/m2 on day -1, and ASCT on day 0. Four additional HDAA doses will be administered 3 days apart on D+2, D+5, D+8, and D+11, followed by weekly doses for four additional weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including tumor response, quality of life, and adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- High Dose Ascorbic Acid (HDAA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor
University of Iowa
Collaborator